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|NCT00605254 : PET Imaging of P-glycoprotein Function Using [11C]dLop|
|Ages||Min: 18 Years Max: 51 Years|
- DESCRIPTION OF STUDY POPULATIONS:
For the dose escalation study using oral tariquidar, we will select healthy adult female
and male volunteers (age 18-51 years old). These healthy volunteers will be medication
free, excluding birth control pills. These subjects will be asked to abstain from any
medications 16 days before and 1 week after participation in the study.
For the AD study, we will select male and female AD patients and age-matched volunteers
who are at least 45 years of age.
1. Patients with the diagnosis of probable Alzheimer disease. All patients must meet
capacity criteria to consent to research (see Consent documents and process).
2. Healthy volunteers.
1. Current psychiatric disease, illicit substance use, or severe systemic disease based
on history and physical exam.
2. Laboratory tests with clinically significant abnormalities. Normal organ and marrow
function are defined as: total leukocyte count greater than or equal to 3000
cells/ul, ANC greater than or equal to 1500 cells/ul, platelet count greater than or
equal to 100,000 cells/ul, serum creatinine less than or equal to 2.0 times the upper
limit of normal, and bilirubin less than or equal to 1.5 times the upper limit of
normal, hemoglobin 9.0 g/dL , serum calcium less than or equal to 12.0 mg/dL, AST/ALT
less than or equal to 1.5 times the upper limit of normal, PT less than or equal to
1.5 times the upper limit of normal.
3. Prior participation in other research protocols or clinical care in the last year
such that radiation exposure including that from this protocol would exceed the
guidelines set by the Radiation Safety Committee (RSC).
4. Pregnancy or breast feeding.
5. Positive HIV test.
6. Positive result on urine screen for illicit drugs.
7. You cannot lie on your back for extended periods of time.
8. Use of blood-thinning medications (such as warfarin; aspirin is allowed), current or
prior history of coagulopathy. This will be necessary only for subjects who have
arterial catheter placement.
9. History of neurological disease other than Alzheimer disease.
10. For oral tariquidar dose-escalation study: Subjects taking medications other than
birth control pills.
11. For Alzheimer s disease patients and age-matched volunteers: Subjects taking
medications that are known substrates of P-gp that cannot be safely discontinued for
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